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Indian Immunologicals Clarifies Abhayrab® Vaccine Safety Amid Counterfeit Reports

Indian Immunologicals Limited has issued a clarification countering a recent Australian health advisory referencing counterfeit batches of its Abhayrab® rabies vaccine from 2023. The company confirmed it proactively identified a packaging anomaly in one specific batch in early 2025 and worked with authorities, stating the counterfeit batch is no longer available. IIL emphasized that all its genuine vaccine batches are tested and released by India's Central Drugs Laboratory before distribution. The manufacturer reassured the public that vaccines supplied through its official channels remain safe and effective.

Key Points: IIL Clarifies Abhayrab® Vaccine Safety, Addresses Counterfeit Advisory

  • Counterfeit advisory addressed
  • Proactive batch anomaly detection
  • 210+ million doses supplied
  • Robust quality systems affirmed
2 min read

Indian immunologicals clarifies on Abhayrab® vaccine, counters misplaced advisory reference

Indian Immunologicals responds to a 2023 Australian advisory on counterfeit rabies vaccines, confirming the safety of its genuine Abhayrab® supply chain.

"The fake vaccine differs from the registered vaccine in formulation, packaging, labelling, and manufacturing. - Australian Technical Advisory Group on Immunisation"

By Shalini Bhardwaj, New Delhi, December 27

Indian Immunologicals Limited, one of India's leading vaccine manufacturers, has issued a clarification regarding recent reports surrounding its human anti-rabies vaccine, Abhayrab®.

The company strongly refuted the over-cautious and misplaced reference to 2023 made in a recent Australian health advisory, stressing that the advisory does not reflect the current situation. Abhayrab® has been manufactured by IIL since 2000, with more than 210 million doses supplied across India and 40 countries, and continues to hold a 40% market share in India.

The Australian Technical Advisory Group on Immunisation has stated that counterfeit (fake) batches of the rabies vaccine Abhayrab® have been circulating in India since 2023.

"The fake vaccine differs from the registered vaccine in formulation, packaging, labelling, and manufacturing. People who received the fake vaccine may not be fully protected against rabies and are advised to get replacement doses to ensure they are adequately protected," said the statement.

Australian Technical Advisory Group on Immunisation has urged travellers to re-vaccination "Travellers to India may be affected if they have received rabies vaccine in India from 1 November 2023 onwards, and were administered one or more doses of Abhayrab®, or the vaccine brand administered is unknown."

In January 2025, IIL proactively identified a packaging anomaly in one specific batch (Batch # KA 24014). The company immediately notified Indian regulators and law enforcement agencies, lodged a formal complaint, and worked closely with authorities to ensure swift action. Importantly, this was an isolated incident, and the counterfeit batch is no longer available for sale.

Reassuring healthcare professionals and the public, IIL emphasised that every batch of vaccine manufactured in India is tested and released by the Central Drugs Laboratory (Government of India) before being made available for sale or administration. Supplies made through government institutions and authorised distributors remain safe and of standard quality.

Sunil Tiwari, Vice President & Head of Quality Management at IIL, stated that IIL aims to reassure stakeholders that the company's pharmacovigilance and quality systems are robust, and that the public can continue to place confidence in vaccines supplied directly by IIL and its authorised channels.

- ANI

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Reader Comments

R
Rohit P
Important to note they identified the issue themselves and reported it. That shows their systems are working. The fake medicine mafia is the real problem here, not the company. Hope the authorities catch them soon.
S
Sarah B
As someone who travels to India frequently, this is concerning. The Australian advisory is for our safety, but it's reassuring that IIL has addressed the issue and it was just one batch. Still, I'll double-check where I get any vaccines from now on.
V
Vikram M
With a 40% market share and 210 million doses, this is a trusted Indian brand. The CDL testing is a crucial safeguard. The real issue is the unchecked sale of spurious drugs by unauthorised chemists. Public needs to be more vigilant.
A
Aman W
While IIL's response is good, this incident highlights a larger systemic weakness in our drug supply chain. One batch of fake vaccines should not be able to enter the market at all. The regulators need to tighten surveillance, not just react after the fact.
K
Kavya N
My dog bit our neighbour's child last year and he was given Abhayrab. Thank God it was from a proper hospital. This news is scary but also a reminder to always go to authorised centres. Don't take chances with rabies!

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